This position will report directly to the Vice President of Medical Affairs and will be an integral member and leader in the Company’s evolving Medical Affairs organization and infrastructure. This person will play a key role in helping to advance Aveo’s novel technology and compounds into clinical trials, with a particular focus on the Tivozanib and Ficlatuzumab Investigator Initiated Trials.
The incumbent will be responsible for strategic development and implementation of the Company’s ISTs with Tivozanib and pipeline products, including the following: design and implementation of sponsored clinical trials, monitoring of such trials and development of a clinical strategy for medical affairs. The person will develop protocols, clinical timelines and study related documents as well as provide overall direction to the clinical sites as Medical Monitor. Further, the incumbent will ensure compliance with all applicable regulatory guidelines.
Additional responsibilities include but are not limited to the following:
Providing medical guidance and leadership in a team environment that includes representatives from AVEO’s Clinical Operations, Clinical Pharmacology, Biometrics, Translational Research, Regulatory Affairs, Commercial and other groups
Presenting AVEO’s clinical programs externally, at meetings with scientific, medical and regulatory (both in U.S. and Europe) authorities
Developing and maintaining relationships with academic investigators, pharmaceutical partners/sponsors (current and new), KOL’s, and patient advocacy groups
Providing clinical information required for INDs, NDAs, and other related documents.
Partnering with pharmacovigilance to assess the safety profile of AVEO compounds
Performing medical review of clinical trial
Collaborating with cross-functional colleagues on publications
Currently, this is an individual contributor in a matrix environment. The initial focus of this position is to support the clinical development of tivozanib leading up to the initial world-wide regulatory submission in the indication of renal cell carcinoma and subsequent development for additional indications as well as the development of a Medical Affairs strategy for pipeline products.
Qualified candidates will have a MD or MD/PhD degree with a minimum of 7 years of experience in oncology Medical Affairs in the industry. Energy and versatility to work in a pre-commercial biotech setting. Excellent communication, presentation and leadership skills are required. Up to 50% domestic and international travel required.
Aveo Oncology - 11 months ago